Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this FOA is to solicit applications for the National Institute of Allergy and Infectious Diseases (NIAID), Clinical Data and Safety Management Center (CDSMC) that will provide data, safety, and pharmacovigilance management and processing, and sample tracking systems for NIAID-funded clinical trials and clinical studies of immune-mediated diseases. The type of research for which support will be provided includes NIAID-supported clinical trials and studies (e.g., investigator-initiated, Network-supported), integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal studies, genetic studies, etc.), and studies to identify and validate surrogates/biomarkers. Current ongoing work supporting within scope functions will transfer at the time of award to the CDSMC grantee.

Background

Research supported and conducted by the NIAID strives to better understand, treat, and prevent immunologic, infectious, and allergic diseases. Within NIAID, the Division of Allergy, Immunology, and Transplantation (DAIT) supports clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history. Many of these studies require long-term, multi-year treatment and observational cohorts, with an emphasis on genetics/genomics proteomic/metabolic analyses, and assessment of lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated consequences of solid organ, tissue and cellular transplantation; (iv) primary immune deficiency disorders; and (v) other immune system disorders. Within these diseases and disorders, research may focus on treatments to enhance immune function or to treat the consequences of immune dysfunction; develop biomarkers of disease activity, immune activation, and immune quiescence; and approaches for the creation of immunologic tolerance.

NIAID has a long history of supporting clinical research and development activities through assistance mechanisms. Within these programs, interactions among NIAID staff (such as Medical Officers/Monitors, Project Managers, Clinical Research Operations Program (CROP), Office of Regulatory Affairs (ORA), the Office of Bioinformatics), and the Project Scientists with the recipient are common as studies are developed and overseen by Clinical Study Teams, which include NIAID staff, Principal Investigators and their staff, and may include members of clinical research organizations (CROs) providing support to NIAID's research, and staff of Pharmaceutical Industry partners.

NIAID provides support to a wide array of clinical trial networks, investigator initiated clinical trials (IICTs) and clinical Study Teams, along with clinical support services. The CDSMC will support and collaborate with multiple clinical research programs, networks and centers including, for example:

Clinical Networks

• Immune Tolerance Network (ITN)
• Asthma and Allergic Diseases Clinical Research Programs
• Atopic Dermatitis Research Network (ADRN)
• Consortium for Food Allergy Research (CoFAR)
• Urban Settings Clinical Research Network (CAUSE CRN)
• Autoimmune Diseases Clinical Research Programs
• Autoimmunity Centers of Excellence (ACE)
• Transplantation Clinical Research Programs
• Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA)

Investigator-Initiated Clinical Trials (IICTs)

• NIAID supports investigator-initiated clinical trials using the R01 or U01 funding mechanism.

Details of specific current research studies to be supported by the CDSMC can be found here. The list of research studies to be supported by the CDSMC will not change while this FOA is active. Note: during the course of the award, research studies will conclude, and additional research studies will be designed and initiated.

Scope and Functional Structure of the CDSMC

Scope

The overall objective of the CDSMC is to provide coordination and oversight for multiple activities in service to clinical research and mechanistic studies supported by NIAID, including for example, data collection, data management, reporting and processing, safety and pharmacovigilance, data support for Data and Safety Monitoring Boards (DSMBs) meetings, and an Electronic Specimen Tracking process for both domestic and/or international research. Thus, the CDSMC must be structured to perform in multiple functional, yet coordinated areas, such as Administrative Oversight, Clinical Data Collection, Management and Processing, Safety and Pharmacovigilance, Data and Safety Monitoring Boards (DSMBs) support and Electronic Specimen Tracking. The primary scientific areas supported through the functions of the CDSMC include, for example, asthma and allergic diseases; autoimmune disorders; immune-mediated consequences of allotransplantation and possibly xenotransplantation; primary immune deficiency disorders; and other immune system disorders and treatments to enhance immune functions. Other NIAID supported research may utilize the functions within the CDSMC under a public health emergency.

The CDSMC will operate in compliance with:

• Current applicable US regulatory authority and/or public laws regulations located at Code of Federal Regulations Title 21 and 45 CFR 46 (e.g., 21 CFR 11, 21 CFR 50, 56, 312, 612 and 812 as applicable, 45 CFR 46 and/or similar statutes), including U.S. Public Law 110-85 or the Food and Drug Administration Amendments Act of 2007, as well as local regulations as applicable.
• Current globally-accepted standards, including the following: International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice, located at ICH Guidance Documents.
• M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries, located at: http://www.ich.org/products/guidelines.html.
• The World Health Organization Drug Dictionary, located at https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/ current industry standards for clinical data management, current example Clinical Data Interchange Standards Consortium (C-DISC) located at: http://www.cdisc.org. Provisions to maintain compliance with changing industry standards must be in place.
• U.S. Department of Transportation (DOT) shipping requirements for biological specimens.

The CDSMC will support and collaborate with Statistical and Clinical Coordinating Centers (SCCCs):

• Allergy Asthma Statistical and Clinical Coordinating Center (AA-SCCC)
• Autoimmune Disease Statistical and Clinical Coordinating Center (AD-SCCC)
• Transplantation Statistical and Clinical Coordinating Center (T-SCCC)

Each statistical and clinical coordination center provides services for NIAID clinical studies, including statistical design and analysis, protocol development, eCRF design, final analysis of study findings, and reporting to DSMBs and other safety committees and Health Authorities as required. The CDSMC will work closely with the SCCCs to develop eCRFs, site training and activation. The CDSMC will provide datasets to the SCCCs and examples of these include data required for analysis, DSMB reporting, study oversight, reporting to health authorities, study close out and archiving.

Functional Structure

Administrative Oversight

The CDSMC will provide Administrative Oversight for all work conducted under the award. In general, administrative oversight consists of developing and implementing a plan to monitor timelines and progress, providing budget and financial management, developing a plan for communicating with NIAID, the NIH Project Scientist and all functional work areas, establishing a comprehensive risk-based approach to quality management, implementing a complete training and technical assistance program for staff to ensure accuracy of clinical safety data and reporting, and developing, cataloging and updating Standard Operating Procedures for all facets of the CDSMC work.

Clinical Data Collection, Management and Processing

The CDSMC will provide secure processes and procedures for data collection, storage, retrieval, quality control, management and disposal for NIAID-funded clinical research and clinical trials. The data process and procedures must work with various NIAID-designated databases/repositories. Within this service area, the CDSMC will coordinate all aspects of data collection, management and processing necessary to achieve the goals of the NIAID-funded specific research, including for example, developing data validation plans, generation of computer-based study forms (e.g., eCRFs), providing reports and data content to various databases (e.g., ImmPort) and implementing a process for disposal of sensitive or controlled data.

Safety and Pharmacovigilance Reporting and Processing

The CDSMC will provide a Safety and Pharmacovigilance Center (SPC) designed to process, analyze, and report adverse events (AEs) and provide comprehensive pharmacovigilance services to NIAID-supported clinical trials. The SPC will provide real-time safety report processing, query generation and resolution, narrative generation and summary reporting, safety and risk management planning, pharmacovigilance services, and processes for safety reporting, data transfers and 24/7/365 unblinding services.

Data and Safety Monitoring Boards (DSMB) Support

The CDSMC will provide data support for safety monitoring by independent DSMBs, Safety Monitoring Committees (SMCs), Independent Safety Monitors (ISMs) and other safety committees established or utilized by NIAID to ensure the safety of clinical trial subjects. This support will include updating data and resolving data discrepancies, providing complete data snapshots to study teams, assist with the preparation of safety reports, and submitting information into various electronic data and safety monitoring systems.

Electronic Specimen Tracking System

The CDSMC will provide and maintain an electronic specimen tracking system that will generate sample labels and shipping information, and track study samples in real time, provide reporting on sample inventory across all specimen repositories and track the lifecycle of each sample from collection through final disposition. The electronic specimen tracking system should have the capability of interfacing with sample tracking systems used by other NIAID supported research, clinical study sites and individual investigators and comply with regulatory requirements for sites and studies collecting and maintaining biological samples.

Additional Resources Provided by NIAID

NIAID will provide access to a number of NIAID-supported resources and systems to the grantee to facilitate coordination and cohesion of research activities.

Clinical Site Monitoring Center (CSMC)

The NIAID CSMC will be responsible for the clinical monitoring of clinical trials and other clinical studies in accordance with protocol-specific and regulatory requirements, including initial site assessments, interim site monitoring of ongoing studies, and site and study close-out.

Immunology Database and Analysis Portal (ImmPort)

ImmPort, supported by a NIAID contract, provides advanced information technology support in the archiving and exchange of scientific data and serves as a long-term, sustainable archive of research and clinical data.

Regulatory Sponsorship and Support & the Regulatory Management Center (RMC)

It is anticipated that, with rare exceptions, NIAID will serve as the regulatory sponsor for clinical trials conducted under Investigational New Drug (IND) Applications, Investigational Device Exemptions (IDEs), and Biologic Licensing Agreements (BLAs), with full responsibility for carrying out sponsor regulatory requirements.

NIAID Clinical Research Management System (CRMS)

NIAID CRMS is a database and data processing service that holds and processes information regarding NIAID's clinical studies.

NIAID Clinical Products Center (CPC)

The NIAID CPC provides support for clinical research programs with respect to the receipt, storage, inventory, packaging, quality assurance, distribution, and disposal of study products.

Investigators interested in additional related FOAs are referred to the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) and the Asthma and Allergy Statistical and Clinical Coordinating Center (AA-SCCC) FOAs.

Please refer to the Frequently Asked Questions (FAQ) page for additional guidance.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution, normally identified by having a Unique Entity Identifier (UEI) or NIH IPF number, is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Kelly Hudspeth, Ph.D.
Telephone: 240-620-1627
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional instructions:

For this specific FOA, the Research Strategy is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Other Attachments:

Transition Plan

The Transition Plan attachment must be in pdf format with a filename of "Transition Plan.pdf." The attachment is limited to 12 pages total and must have clearly marked sections for Initial Transition Plan and Final Transition Plan. Applications lacking the transition plan are incomplete and will not be reviewed.

Initial Transition Plan

Currently, the functions of the CDSMC are incorporated in an ongoing award that also supports additional functions (https://reporter.nih.gov/search/IwexnTgTYU2ne1l68kdbDQ/project-details/10589242). The data that will be transitioned is currently managed using Medidata's cloud-based Rave Electronic Data Capture (EDC) software, Oracle Argus safety database software, with a few studies utilizing an instance of RedCap hosted by NIAID.

Include an Initial Transition Plan that describes plans, procedures and timelines to ensure an orderly, secure and efficient initial transition of all CDSMC study related materials, data, programming, forms, standard operating procedures, and any other related documents and to assume all CDSMC study activities, as described in the FOA. Include discussion of any intended software systems, compatibility issues and quality control approaches to ensure a seamless transition without loss of time, loss of essential services or that would not pose obstacles to the conduct of ongoing clinical trials. Data and materials to be transitioned include the following:

• Complete clinical and safety databases including audit trails; hard copies of the original data when required and all logs and records related to data collection, entry, editing, verification, analysis and transfer;
• Complete specimen tracking and mechanistic and "omics" databases;
• Draft protocols for clinical trials and studies in development, final protocols and protocol amendments for ongoing clinical trials and studies, and final protocols and protocol amendments for completed clinical trials and studies;
• All analysis datasets for clinical (DSMB, interim and final analyses and mechanistic studies);
• All other study-related materials for ongoing and completed clinical trials and studies, as well as clinical trials and studies in development, including informed consent forms, case report forms, manuals of operations, investigator brochures, and other documents;
• Data and other information contained in study-specific websites and procedures for access control;
• User manuals and all written instructions for utilization of the data management system, as applicable;
• Instructions and standard operating procedures for clinical data and safety reporting;
• All materials prepared for meetings, teleconferences and responses to inquiries from the FDA and other regulatory authorities; and
• A list of all computer programs used for reading, cleaning, manipulating and analyzing data and programs used for generating new datasets.

Final Transition Plan

Include a Final Transition Plan that describes plans to maintain full operational capacity until the completion date of the grant with the stipulation that Final Transition must be fully completed by the expiration date of the grant. Plans should include coordination and implementation of an orderly, secure, and efficient transition of all data, protocol-related documents, standard operating procedures, and other materials. CDSMC- materials and data to be transitioned include the following:

• All items listed in the Initial Transition above, and
• if not already provided, clean, edited datasets for ongoing studies and study analyses, public use datasets (including cleaned data with or without images, raw data if cleaned data are not available) and copies of all data management tools, including data documentation, data dictionaries, and data entry software and editing programs to allow reading and analysis of the data for all studies managed under the CDSMC award. This includes all computer programs and custom coding used for reading, cleaning, manipulating, graphing and analyzing data and programs used for generating new datasets; audit trails of all data corrections, hard copies of the original data, if collected under this grant, and all logs and records related to data collection, entry, editing, verification, analysis and transfer; final summaries of data analyses performed during the grant period of performance; all electronic files transferred and documentation of format to a location specified by NIAID by the grant completion date; and hard copy files when required, including all reports submitted to NIAID, in an organized manner, providing clear documentation of contents, date of origin, and purpose to a location specified by NIAID prior to the award completion date.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Within the biosketch describe the PD(s)/PI(s) experience with respect to complexity, size and scope of the programs and projects the CDSMC supports. In addition, describe the PD(s)/PI(s) experience in implementing, tracking, coordinating, and managing multiple activities in support of large and complex clinical research programs. Finally, provide the PD(s)/PI(s) experience with communicating and interacting with government-supported research networks, consortia and individual NIAID-funded investigators.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Within the appropriate budget sections, in addition to the budget instructions, consider the following information when developing the CDSMC Budget:

• Applicants should budget for the PD/PI(s) role at a minimum of eight (8) person months per year to provide direction, leadership, and oversight for the program.
• Study populations may include pregnant mothers, neonates/infants, children, adolescents and/or adults, with most studies being conducted under INDs.
• 65-70 clinical trials in Phase I, II, or III at any given time, with 20% in development, 30% recruiting/treating/following subjects, 35% last patient off study to Final Report, and 15% preparing for archiving.
• At the time of award, the approximate number of studies will be:
  

• 14 in development
• 21 recruiting/treating/following participants
• 25 between last participant off study to Final Report
• 10 preparing for archiving
  

• Include funds to support travel for the PD/PI(s) and one other key personnel to attend multiple meetings:
  

• Two meetings per year, 3-day, 2-night located in Washington D.C. area
• Two meetings per year, 3-day, 2-night located on the U.S west coast
• Two meetings per year, 3 day, 2-night located in the U.S. mid-West
• Two meetings per year, 3-day, 2-night located on the U.S. east coast
  

• Annually 20-25 SMPs, 250 Serious Adverse Events (SAEs) resulting in 250 Medical Summary Reports, 250 eCRFs, 400-450 dispositions and applicable source documentation
• Sample tracking from multiple sources required for approximately 30,000 samples at time of award, with estimated 10,000 - 15,000 samples added annually over the life of the award
• Support for 30-35 DSMB meetings per year

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Briefly describe the specific aims of the CDSMC with respect to the overarching objectives of the program and how meeting these objectives will optimize the implementation, conduct, and close-out of clinical trials and clinical research studies in disease-specific areas.

Research Strategy: Within the following labeled areas below, provide plans, approaches, processes, and procedures to fulfill the requirements of the CDSMC.

Administrative Oversight

• Describe a staffing plan for the CDSMC, indicating the types of positions (e.g., clinical data manager), degree (e.g., doctoral degree) required and role in the CDSMC, to include all positions. Indicate if individuals are currently available or will be recruited for positions. Do not duplicate information in the biosketch. Tables, diagrams, flow charts and organizational charts may be provided in describing the proposed structure, operation, lines of authority and staffing of the group.
• Describe how the CDSMC will provide in-country representation for any CDSMC function when required by governing health authorities.
• Describe the plans for ensuring effective communications by the CDSMC, including how information will be communicated to/from/among the various functional areas to support efficient, rapid and clear communications. Describe how the CDSMC leadership will communicate with NIAID and NIAID-provided contract resources to receive and provide updates and bi-directional communications of needs and requirements.
• Describe the process for decision making, resolving operational issues, and for assessment of deficiencies in the operations of the CDSMC. Discuss how deficiencies will be remediated and how such changes will be conveyed and implemented.
• Describe how progress will be monitored and reported. Provide a detailed plan for the management of the entire CDSMC, including for example, roles and responsibilities of staff within each functional area, how specific activities will be planned, approved, tracked, and monitored for progress. Discuss risk mitigation strategies.
• Describe the administrative functions related to fiscal and budgetary operations and management, and how specific resources will be requested and provided, and how these requests for resources will be prioritized.
• Describe additional groups, committees, areas of organizational need for daily operations of the size and scope of this project.
• Describe the approach to quality management within the CDSMC and provide the plans, procedures, timelines and standards to be met regarding quality management, processes, control, including the integration and coordination of all functions within the CDSMC. Discuss the tools and metrics that allow for a systematic assessment of quality management and the process for remediation and correction.
• Describe plans for developing and implementing standard operating procedures (SOPs) for all CDSMC functions, and discuss the process for revising, updating and retiring CDSMC SOPs during the lifecycle of the award.
• Describe the plan to provide staff training and technical assistance for all functional areas associated with the CDSMC, including the format, timing, and post-training evaluation for each training provided.
• Describe how the CDSMC will maintain compliance with the legal, regulatory, quality, and data standards.

Clinical Data Collection, Management and Processing

• Describe the proposed Electronic Data Capture system used to carry out the functions of the CDSMC. Discuss how this system will capture, view, store and transfer data within the CDSMC.
• Describe the process for generating the computerized study forms, including eCRFs and safety reporting forms for clinical data entry and transmission, and how the safety forms will be transmitted to NIAID.
• Describe the approach and timing for data quality checks, validation, data cleaning and reconciliations of clinical and safety databases.
• Describe how official sponsor safety documentation will be transmitted to NIAID.
• Describe the security measures to protect study data including labeling, storage, handling, transfer and disposal of sensitive or controlled data.
• Describe the overall approach for reviewing, cleaning, updating, and reconciliation of the data within the clinical database. Discuss the optimal internals and timelines for performance of these activities.
• Describe how genetics/genomics, proteomic/metabolic analyses, and assessment of lifetime exposures data will be housed.
• Describe the security features of the location of the database(s) including duplication and redundancy, and the security features that protect the data from unauthorized access, or data entry and to prevent theft.
• Describe the duplication of back-up efforts in the event of emergency situations.
• Describe the flexibility in data management and reporting operations and systems in the event of an increase in the number of trials/studies or changes in the nature of data reported (e.g., genetics/genomics or proteomic/metabolic analyses).

Safety and Pharmacovigilance Reporting and Processing

• Describe the process, procedure and systems associated with safety and pharmacovigilance reporting and processing for domestic and international studies.
• Describe the procedure needed to capture, assess, analyze, and report adverse events of all types (e.g., AEs, SAEs, SUSARs, etc.). Discuss approaches to remediate potential problems.
• Describe the process of developing protocol-specific safety related eCRFs and eCRF completion guidelines.
• Describe safety study close out activities.
• Describe the approach for monitoring protocol safety stopping rules
• Describe the process for responding to Sponsor audits and Health Authority inspections, and the plans and procedures to respond to queries, audits or inspections of the safety or pharmacovigilance functions or databases of the CDSMC.

Data and Safety Monitoring Boards (DSMB) Support

• Describe plans and processes to develop the required data reports necessary for both planned and ad hoc DSMB reviews and other data safety reviews.

Electronic Specimen Tracking System

• Describe the features of the proposed electronic specimen tracking system to ensure accurate labeling, packing, shipping and receipt information in real-time, procedures for secure transportation and receipt of the specimens, and the inclusion of consent information associated with the sample use.
• Describe the approach for reporting on sample inventory across all specimen repositories and tracking the lifecycle of each sample from collection through final disposition.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should provide a Data Sharing Plan.As part of the Data Sharing Plan, applicants should detail the procedures for sharing, release, and access of the data and data analyses generated to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data Management and Sharing Guidelines.
• Awardees should deposit data and data analyses into ImmPort or other public data portals as designated by NIAID. The Data Sharing Plan must ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR) per the NIAID Data Management and Sharing Guidelines as appropriate and consistent with achieving the goals of the program.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAID, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA:

Does the application provide critical clinical research support services, including management and communications, that will foster efficient, high-quality, timely, accurate, and relevant data in support of multiple scientific disciplines?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific for this FOA:

Is the level of commitment of the PD/PI(s) adequate to manage the overall project and is the experience of the PD/PI(s) reflective of a range of administrative, scientific, and management skills associated with administration and oversight for a complex project of the size, scope and importance of the CDSMC?

Do the PD(s)/PI(s) and/or Senior/Key personnel have the appropriate experience with respect to complexity, size and scope of the programs and projects the CDSMC supports?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA:

• Does the organizational structure and staffing plan for the CDSMC support the breadth and scope of work described in the application?
• Are the plans for ensuring effective communications by the CDSMC, including communicating to/from/among the various functional areas sufficient?
• Are the plans for communicating between the CDSMC leadership and NIAID, and NIAID-provided contract resources bi-directional and sufficient?
• Are the plans for preparation of data reports to DSMBs adequately described and feasible for ad hoc and routine meeting needs?
• Are the measures proposed to safeguard data systems adequate to prevent theft, unauthorized access or data entry, and do they provide for duplication or back-up efforts in the event of emergency situations?
• Do the procedures for specimen tracking ensure secure transportation and receipt of the specimen?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Clinical Data Collection, Management and Processing

• Are there sound, appropriate, feasible standards and criteria for clinical data collection, management and processing?
• Is the proposed system for electronic data capture (EDC) adequate to meet the needs of the program?
• Is there sufficient flexibility of the proposed data management and reporting operations and systems in the event of an increase in the number of trials/studies or changes in the nature of data reported (e.g., genetics/genomics or proteomic/metabolic analyses)?
• Are the plans for data cleaning and reconciliation appropriate for the volume of data within the CDSMC?

Safety and Pharmacovigilance Reporting and Processing

• Are there sound, appropriate, feasible standards and criteria for safety and pharmacovigilance reporting and processing?
• Does the application describe a safety and pharmacovigilance system that will address the needs of the project?
• Does the application discuss common problems and difficulties associated with capturing, assessing, analyzing, and timely reporting of adverse events, and approaches to remediate problems?
• Are the plans and procedures for safety and pharmacovigilance appropriate to ensure data integrity for complex studies across the clinical research support services of the CDSMC?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases (NIAID), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Providing leadership, direction and oversight for all activities conducted within the scope of the CDSMC.
• Adhering to established methods and procedures for assessment of progress and productivity of the work conducted within the CDSMC and implementing changes to optimize performance.
• Establishing procedures for communications within and beyond the CDSMC and ensuring appropriate lines of communications between the individual CDSMC work units and NIAID-provided contract services.
• Ensuring the performance of CDSMC functions support adherence to and complies with all Federal and where appropriate, State and country-specific regulatory requirements and guidelines for the conduct of human subject's research, as well as NIH and NIAID policies and procedures.
• Providing financial accountability for all work performed by the CDSMC and supplying periodic budget summaries to the NIH Project Scientist.
• Implementing required training programs and certifications for CDSMC staff and recording progress and completion annually.
• Transferring study related data in formats compliant with the DAIT CRIS, ImmPort, ClinicalTrials.gov, NIAID supported clinical research programs and pharmaceutical collaborators, and ensure that the NIAID Data Sharing Plan is properly implemented. Ensure complete transfer of all study related data before the end of the award.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond the normal program stewardship role for grants.The NIH Project Scientist will provide leadership in this role and will be supported by other NIAID staff. The NIH Project Scientist will:

• Periodically review data and materials generated under the CDSMC and use this information for the preparation of internal reports.

• Facilitate collaborations with and provide access to other NIAID-supported research resources and services.
• Review and assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
• Facilitate consensus and participate in the decision-making process on various matters to ensure appropriate oversight and approval.
• Provide access to reports, SAEs, and protocol deviations in cases where NIAID serves as the regulatory sponsor for clinical trials conducted under INDs/IDEs and facilitate the preparation of reports and documents required for regulatory submissions.
• Provide documentation to support NIAID's right to terminate, curtail or suspend a clinical trial/study for any reason.
• Additionally, an NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Ensuring consistency of the CDSMC functions with the NIAID-supported clinical network agendas and relevance with the NIAID scientific priorities.
• Reviewing the CDSMC activities and goals on an agreed-upon schedule (but no less than once every year). Promoting, evaluating, and executing opportunities to collaborate with other federal or non-federal research sponsors.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Leighton Thomas
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3522
Email: [email protected]

Kelly Hudspeth, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-620-1627
Email: [email protected]

Elizabeth Sihombing
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5530
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.